Proposed changes to condom regulations
The Food and Drug Administration (FDA) recently published information about proposed changes in the way condoms are to be regulated, and draft guidelines for condom labeling.
FDA sets regulatory controls on medical devices. The least restrictive level is general controls. General controls can include good manufacturing practices/quality system regulation, registration and listing, adverse event reporting, and the prohibitions on adulteration and misbranding.
Another level of control is known as special controls. The way a device is labeled can be considered part of special controls.
FDA believes that special controls (in this case special labeling), when combined with general controls, will be sufficient to provide a reasonable assurance of the safety and effectiveness of latex condoms, with or without spermicidal lubricant.
FDA is proposing to amend the classification regulations to designate a special control for natural rubber latex (latex) condoms, with and without spermicidal lubricant. New guidelines (below) specify the kind of labeling that will be considered sufficient and appropriate for the products.
Three separate documents were published on Nov. 14, 2005 to support these proposed changes:
- Proposed Rule-Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant www.fda.gov/OHRMS/DOCKETS/98fr/05-22611.htm. This document explains the regulatory structure for devices of this class.
- Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex-www.fda.gov/OHRMS/DOCKETS/98fr/05-22610.htm. A Notice of Availability of the Guidance, which includes a very good overview of the regulatory history of condoms.
- Draft Guidance-Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex -www.fda.gov/cdrh/comp/guidance/1548.html. The draft guidance, which explains the specific labeling requirements considered to be special controls, including labeling recommendations intended to help address issues related to nonoxynol-9 (N-9), used as a spermicide in the lubricant of some latex condoms.
The labeling recommendations in the draft guidance reflect an extensive review by FDA, in consultation with the National Institutes for Health (NIH) and the Centers for Disease Control and Prevention (CDC), of the available medical literature on the safety and effectiveness of condoms intended to prevent pregnancy and provide protection against sexually transmitted diseases (STDs). In addition, the agency considered other relevant information related to the barrier properties of latex condoms and the various routes of transmission of STDs.
Interested parties are encouraged to comment on the proposals. Instructions for submitting comments are provided within the linked documents.
FDA postpones CCR5 Antagonist Review Group meeting
After reviewing the current CCR5 antagonist development issue, the FDA CCR5 Antagonist Review Group and the Forum for Collaborative HIV Research have decided to postpone the meeting to discuss the long-term follow up of patients enrolled in CCR5 antagonist clinical trials until February or March of 2006.
The original Jan. 18th date was chosen to address the long-term follow up issues in as timely a manner as possible. However, because additional clinical trial data is accumulating, waiting until as much information as possible is available will ensure that the public discussion is as effective as possible.
An announcement will be sent once the exact meeting date is established.
We still encourage input from the patient and advocacy communities and academia to ensure your suggestions and concerns are taken into consideration as we prepare for this important meeting.
Please use the website at www.hivforum.org/CCR5/index.html to provide input. Please provide your comments by Jan. 15, 2006.
World AIDS Day comments by FDA's HIV/AIDS program director
From the first, isolated reports in 1981, AIDS has grown into a global pandemic. Despite efforts in every nation, the epidemic continues to grow. While HIV/AIDS seems to have faded somewhat into the background in the United States, rarely making front page headlines as it has in years past, the epidemic is still present in this country. There are more than a million people living with HIV and AIDS in the United States today, and an estimated 38 million worldwide.
AIDS and HIV infection have become part of the American narrative over the past twenty four years. It is a now part of the fabric of our nation, and that of nations around the world.
FDA has played a strong role in addressing treatment and prevention from the beginning of the epidemic. FDA has made significant contributions to the development and availability of potent antiviral drugs that have dramatically helped people with HIV and AIDS live longer, healthier lives.
The agency has played an important role in improving medical treatments, providing access to promising investigational products, helping to prevent the transmission of HIV through regulation of barrier products, protection of the blood supply, and oversight of the development of vaccines (both preventive and therapeutic) and microbicides.
World AIDS Day commemorates those that have died from AIDS. It also serves as an opportunity to think about how we can help support the individuals, families, and communities affected by HIV and AIDS, and renew our commitment to preventing the spread of the disease, developing and delivering more effective treatments, and finding a cure.
You can find a comprehensive chronology of significant events in FDA's involvement in the fight against HIV on the FDA website at www.fda.gov/oashi/aids/miles.html
The Food and Drug Administration (FDA) recently published information about proposed changes in the way condoms are to be regulated, and draft guidelines for condom labeling.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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